HEPSERA Drug Patent Profile

Which patents cover Hepsera, and when can generic versions of Hepsera launch?

Hepsera is a drug marketed by Gilead and is included in one NDA.

The generic ingredient in HEPSERA is adefovir dipivoxil. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hepsera

A generic version of HEPSERA was approved as adefovir dipivoxil by SIGMAPHARM LABS LLC on August 29^th, 2013.

Summary for HEPSERA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	19
Drug Prices:	Drug price information for HEPSERA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HEPSERA
What excipients (inactive ingredients) are in HEPSERA?	HEPSERA excipients list
DailyMed Link:	HEPSERA at DailyMed

See drug prices for HEPSERA

Recent Clinical Trials for HEPSERA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Yeungnam University	Phase 4
Keimyung University Dongsan Medical Center	Phase 4
DongGuk University	Phase 4

See all HEPSERA clinical trials

Paragraph IV (Patent) Challenges for HEPSERA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HEPSERA	Tablets	adefovir dipivoxil	10 mg	021449	1	2010-06-08

US Patents and Regulatory Information for HEPSERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002		DISCN	Yes	No

Expired US Patents for HEPSERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002

EU/EMA Drug Approvals for HEPSERA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Hepsera	adefovir dipivoxil	EMEA/H/C/000485 Hepsera is indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease with evidence of active viral replication, persistently elevated serum-alanine-aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis. Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1);decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.	Withdrawn	no	no	no	2003-03-06

International Patents for HEPSERA

See the table below for patents covering HEPSERA around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20060038364
Hong Kong	217296	Phosphonylmethoxy alkyl adenines for the treatment of virus diseases
European Patent Office	1256585	Procédé de préparation de la 9-(2-(diéthylphosphonomethoxy)éthyl)-adénine (Process for preparing 9-(2-(diethylphosphonomethoxy)ethyl)-adenine)
Germany	69826734

Supplementary Protection Certificates for HEPSERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0481214	C300131	Netherlands		PRODUCT NAME: ADEFOVIR DIPIVOXIL, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE ZUURADDITIE ZOUTEN, METAALZOUTEN EN SOLVATEN HIERVAN; NAT. REGISTRATION NO/DATE: EU/1/03/251/001 20030306; FIRST REGISTRATION: EU/1/03/251/001 20030306
0481214	03C0034	France		PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306
0481214	91036	Luxembourg		91036, EXPIRES: 20160910
0481214	SPC/GB03/030	United Kingdom		PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTERED: UK EU/1/03/251/001 20030306

HEPSERA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Hepsera (Adefovir Dipivoxil)

Introduction to Hepsera

Hepsera, also known as adefovir dipivoxil, is a nucleotide analog reverse transcriptase inhibitor used primarily in the treatment of chronic hepatitis B. Developed by Gilead Sciences, it has been a cornerstone in the management of this viral infection.

Market Growth and CAGR

The viral hepatitis market, which includes treatments like Hepsera, is expected to grow at a Compound Annual Growth Rate (CAGR) of 2.69% from 2024 to 2034. This growth is driven by the increasing adoption of innovative antiviral therapies, including direct-acting antivirals (DAAs) and other advanced treatments like Hepsera[1].

Key Drivers of the Market

Innovative Antiviral Therapies

The success of Hepsera and other antiviral medications is a significant driver of the market. Hepsera, in particular, has shown substantial improvements in liver histology and reductions in viral load, especially in patients with precore mutant chronic hepatitis B virus infection[1].

Digital Health Technologies

The integration of digital health technologies such as telemedicine and mobile health apps enhances patient management and monitoring, contributing to the overall growth of the market. These technologies improve adherence to treatment and provide better outcomes for patients using Hepsera and other antiviral medications[1].

Financial Performance of Hepsera

Historical Sales Data

In the fourth quarter of 2003, sales of Hepsera totaled $15.8 million, slightly lower than the $16.4 million in the third quarter of 2003. This decrease was primarily due to reductions in U.S. wholesaler inventory levels, although prescription growth for Hepsera increased by 18% quarter over quarter[2].

Recent Market Trends

While specific recent sales figures for Hepsera alone are not readily available, the overall liver disease segment, which includes Hepsera, has shown mixed results. In the fourth quarter of 2023, sales in this segment were driven by higher HCV market share and growing demand for HDV treatments in Europe, despite unfavorable pricing dynamics[3].

Competitive Landscape

Market Share and Competition

Gilead Sciences continues to be a leading player in the viral hepatitis market, with Hepsera being one of its key products. The company's strong portfolio, including other successful drugs like Viread (tenofovir disoproxil fumarate) and Epclusa, helps maintain its market share. However, the market is competitive, with other major players such as F. Hoffmann-La Roche, Bristol Myers Squibb, and AbbVie Inc.[4].

Clinical Developments and Efficacy

Long-term Efficacy and Safety

Recent clinical studies have reaffirmed the long-term efficacy and safety of Hepsera. A Phase III clinical study confirmed the effectiveness of adefovir dipivoxil in patients with precore mutant chronic hepatitis B virus infection, showing significant improvements in liver histology and reductions in viral load[1].

Regional Market Dynamics

North America

North America holds the largest share in the hepatitis therapeutics market, driven by the rise in prevalence of hepatitis, government initiatives, and the implementation of cutting-edge treatment approaches. Hepsera, being part of this market, benefits from these favorable conditions[4].

Europe and Other Regions

In Europe, Hepsera has seen growing demand, particularly for the treatment of HDV. The market dynamics in other regions, such as Asia Pacific, are also influenced by the availability and adoption of advanced antiviral therapies like Hepsera[4].

Future Outlook

Market Projections

The hepatitis therapeutics market, including treatments like Hepsera, is projected to grow at a CAGR of 3.6% from 2023 to 2031, reaching a value of US$ 21.9 billion by 2031. This growth is expected to be driven by continued advancements in antiviral therapies and increasing demand for effective treatments[4].

Financial Projections for Gilead Sciences

Gilead Sciences, the manufacturer of Hepsera, expects its product sales excluding Veklury to grow by 4-6% in 2024 compared to 2023. While specific projections for Hepsera are not detailed, the overall growth in the liver disease segment and the company's strong portfolio suggest a positive financial trajectory[3].

Key Takeaways

• Market Growth: The viral hepatitis market is expected to grow at a CAGR of 2.69% from 2024 to 2034.
• Innovative Therapies: The success of antiviral therapies like Hepsera drives market growth.
• Digital Health: Integration of digital health technologies enhances patient management.
• Financial Performance: Historical sales data shows steady performance, with recent trends influenced by market dynamics.
• Competitive Landscape: Gilead Sciences remains a leading player with a strong portfolio.
• Clinical Developments: Long-term efficacy and safety of Hepsera have been reaffirmed by clinical studies.
• Regional Dynamics: North America and Europe are key regions driving the market.

FAQs

What is Hepsera used for?

Hepsera, or adefovir dipivoxil, is used primarily in the treatment of chronic hepatitis B.

What is the expected growth rate of the viral hepatitis market?

The viral hepatitis market is expected to grow at a CAGR of 2.69% from 2024 to 2034.

Who is the leading manufacturer of Hepsera?

Gilead Sciences is the leading manufacturer of Hepsera.

What are the key drivers of the market for Hepsera?

The key drivers include the increasing adoption of innovative antiviral therapies and the integration of digital health technologies.

What is the projected value of the hepatitis therapeutics market by 2031?

The hepatitis therapeutics market is projected to reach a value of US$ 21.9 billion by 2031.

Sources

1. Biospace: "Viral Hepatitis Market Estimated to Reach a CAGR of 2.69% during 2024-2034"
2. Gilead Sciences: "Gilead Sciences Announces Fourth Quarter and Full Year 2003 Financial Results"
3. Gilead Sciences: "GILD Q4 & FY23 Summary of Prepared Remarks Q423"
4. Transparency Market Research: "Hepatitis Therapeutics Market Size, Share Report, 2031"